8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
FDA 510(k)
FDA Class 2
·Cardiovascular
PRESS-FIT HEAD RESURFACING DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
MBT CEM KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2011
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012